FDA.report

510(k) K232546

Device
Meta G UCLA Abutment
Applicant
Cowellmedi Co., Ltd.
510(k) number
K232546
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-21
Date received
2023-08-23
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Haejun Lee
Address
48, Hakgam-Daero 221beon-Gil, Sasang-Gu Busan KR 46986 46986

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08800016106862Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016106855Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016106800Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016106794Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016106060Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016106053Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016106046Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016106039Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016104493Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016104486Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016103939Meta G UCLA Abutment-Abutment ScrewCowellmedi Co.,Ltd2024-05-24
08800016101041Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24
08800016101034Meta G UCLA Abutment-Meta G UCLA AbutmentCowellmedi Co.,Ltd2024-05-24

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